The Biostatistics Shared Resource (BSR) provides statistical support and services to the Hollings Cancer Center (HCC) investigators. Specific services include assistance with grant and trial development, data analysis, clinical trial review and monitoring and education. For grant and protocol development, the BSR nelps HCC investigators by assisting with defining aims and outcomes, selecting an appropriate study design, developing a statistical analysis plan, and performing sample size calculations to determine and justify the number of subjects or patients included in the study. The HCC BSR also actively assists with data analysis in a number of settings, including manuscript and abstract preparation, preliminary data for grant submissions, and for pilot projects supported by HCC. The faculty of the BSR participates in the HCC Protocol Review and Data and Safety Monitoring Committees providing critical review of trials and in providing educational opportunities to faculty, fellows, residents and staff of the HCC. There are currently four statisticians in the BSR. The BSR has provided services to all four HCC research programs presented in this application and to a developing program in cancer prevention and control. Since the new BSR Director was appointed in February 2007, usage of the BSR has increased dramatically. Thirty-seven grants have been submitted in the previous calendar year, and 27 manuscripts and abstracts submitted with the support of the BSR. These efforts demonstrate the current high utilization of the BSR by HCC investigators, and a strong commitment of the BSR to the research goals of the HCC. The specific purposes of the BSR are to: Collaborate with HCC investigators in study development, implementation, and publication by providing assistance with study design, statistical analysis plans, sample size considerations, statistical analysis, and grant and manuscript preparation Utilize, adapt and develop novel statistical methodologies, as needs arise, to respond to challenging research issues in ongoing HCC research Serve on clinical trial review and monitoring committees within the HCC providing critical reviews of proposed and ongoing internal and external clinical trials Provide ongoing education in statistical methods and approaches for members of the HCC